1. Field of the Invention
The present invention relates to multiple dosage medicine drop bottle comprising a germicide and a method for reducing or eliminating the risk of contamination of the multiple dosage medicine drop bottle and its contents.
2. Description of the Related Art
TIMOPTIC.RTM. is the registered trademark for a sterile ophthalmic solution produced by Merck & Co., Inc., West Point, Pa. Each ml of TIMOPTIC.RTM. 0.25% contains 3.4 mg of timolol maleate (equivalent to 2.5 mg of timolol), monobasic and dibasic sodium phosphate, sodium hydroxide (to adjust pH), benzalkonium chloride 0.01% and water. TIMOPTIC.RTM. is also available as a 0.5% ophthalmic solution.
Timolol maleate is the active ingredient and benzalkonium chloride is added as a preservative. Timolol maleate is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (S)-1-[(1,1-dimethylethyl)amino]-3-[[4-(-morpholinyl)-1,2,5-thiadiazol-3-y l]oxy]-2-propanol, (Z)-2-butenedioate (1:1) salt.
The instructions accompanying the 10 and 15 ml OCUMETER.RTM. ophthalmic dispenser bottle for TIMOPTIC.RTM. ophthalmic solution states "To avoid contamination, be careful not to touch the dropper or let it touch your eye". The instruction pamphlet accompanying the 10 and 15 ml OCUMETER.RTM. bottle further states:
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures. PA1 Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
As a practical matter it is almost impossible with self-administered droppers, e.g., for eye drops, ear drops, nose drops, not to touch the body, e.g., the skin and/or eyelashes, the skin and/or otic hairs, the skin and/or nasal hairs, when using such droppers. With single dose dispensers, there is no serious problem with contamination. With containers designed for repeated dosages (such as 1, 5, 10 and 15 ml bottles), there is, however, the danger that microbes from the skin and hair will contaminate the bottle and/or solution as the result of the contact of the dropper end of the bottle with the skin and/or hair during the administration of the solution. The next time that the medicinal solution is administered, it may be contaminated with the undesirable microbes, e.g., bacteria, fungi.
The danger of contamination is further increased by the fact that the microorganisms will have time to multiply during the normal time lag between administering dosages. TIMOPTIC.RTM. Ophthalmic Solution is usually administered twice a day or every twelve hours. Under favorable conditions, many bacteria double every half hour. Thus, if any of the liquid from the dropper happens to remain on the area of the bottle which contacted the skin and/or hair of the eyes, ears or nose, the risk of undesirable microorganism growth is increased.
I have now found that this danger of contamination can be reduced or eliminated if the spout end of a multiple dosage medicine plastic bottle is provided with a germicide, e.g., a bactericide, fungicide or an oligodynamic metal.
In a second aspect of the present invention, a multiple dosage bottle can contain another medicine which is useful as an anti-clotting agent in addition to the eye, ears or nose drops.